NCT03656315

Brief Summary

This study looks to devise a scoring system that can be used to predict difficult front of neck access due to increased depth of cricothyroid membrane. This study will recruit elective patients undergoing operations for a variety of procedures and correlate their measured (by ultrasound) cricothyroid depth with other difficult airway predictors (such as Mallampatti score).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

September 14, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

November 2, 2022

Status Verified

March 1, 2021

Enrollment Period

3.5 years

First QC Date

August 15, 2018

Last Update Submit

October 31, 2022

Conditions

Airway Obstruction

Keywords

Difficult airwayCricothyroid membraneAssessment

Outcome Measures

Primary Outcomes (1)

  • Correlation between difficult airway indicators and cricothyroid membrane

    A positive correlation between airway assessment parameters and depth of the cricothyroid membrane

    20 minutes

Secondary Outcomes (1)

  • A scoring system to predict the depth of cricotyroid membrane

    20 minutes

Study Arms (1)

Airway assessment

OTHER

All patients recruited will be entered into this arm of the study. Airway assessment including Ultrasound scan will be performed

Other: Airway Assessment

Interventions

Airway AssessmentOTHER

All patients recruited to this study will have an ultrasound of their cricothyroid membrane

Airway assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cases

You may not qualify if:

  • Emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: All recruited participants will be included in the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist

Study Record Dates

First Submitted

August 15, 2018

First Posted

September 4, 2018

Study Start

September 14, 2018

Primary Completion

February 25, 2022

Study Completion

February 25, 2022

Last Updated

November 2, 2022

Record last verified: 2021-03

Locations

GB(1)